Job title: Quality Systems (Change) Analyst
General job summary
The Quality Systems Analyst (Change Control) is the Change Analyst for Document Control
and Change Control.
The Quality Systems Analyst ensures the continuous education, implementation and improvement of Quality Systems and compliance with QS Regulation and ISO within the Leiden facility. The Quality Systems Analyst ensures that the Leiden Plant, Document Control and Change Control Processes and structure meet all business and regulatory requirements.
Responsible for Site Records Management and Site Record Management representative for Leiden
Principle duties and responsibilities
1. Ensures quality systems are effectively deployed.
2. Performs periodic checks to verify appropriate application.
3. Maintain regular interface with Management:
* To assist in the development of Quality Metrics.
* To achieve company's Quality goals.
4. Uses statistical methods, quality tools and computer generated reports to
continuously improve process capability
5. Provide education/training as needed regarding Document Control and Change Control processes including MVI/Validation Documents.
6. Leads and participates in quality system improvement initiatives.
7. Conducts internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements.
8. Determines root causes of quality issues and develops corrective actions and recommendations.
9. Suggests process changes when appropriate.
10. Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business.
11. Assists department head in implementing new product development procedures and documentation.
12. Assists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely manner.
13. Responsible for the Site Records Management being the Site Record Management representative:
* Executes the RM Program for each Site that they are responsible for.
* Ensures RM requirements and procedures align to the Franchise RM Policy, and the WWRIM Policy and associated Standards.
* Ensure appropriate training on RM requirements is available and provided to associates in order to enable compliance with those requirements.
* Comply with WWRIM program requirements including but not limited to submitting annual reports to WWRIM, completing an annual program assessment, etc...
* Provide program updates on RM activities to Management and the WWRIM office;
* Provide guidance for the identification and protection of the company's Vital Records.
* Work with business units/departments to create, implement, and maintain a Records Retention Schedule;
* Conduct or facilitate RM Compliance Assessments with the business units/departments;
* Implement and manage RM services such as inactive storage solutions and/or acquire such services and other RM products provided by external vendors, as appropriate.
14. Backup on other tasks within QS department to assure business continuity, if required;
Required Education and Qualifications
* University/Bachelor's Degree or Equivalent
* Minimum of Lean/Six Sigma Green Belt is desired for this position, and also background in Statistics.
* Able to communicate and writing skills in English
* Mathematical and analytical thinking skills
Level of Experience
* Requires a minimum of 2 years related experience. Medical device manufacturing experience preferred.
Thorough understanding of medically regulated plant operations including knowledge of industry standards & regulations, processes and practices in a variety of different departments and operations preferred.
Experience with audits preferred (Notified bodies and/or Competent Authorities).
* Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
* Ability to write reports, business correspondence, procedure manuals and related documentation that conform to prescribed style and format.
* Ability to effectively present information and respond to questions from groups of managers, clients, and customers
s.kolks(at)realstaffing.com / 020 522 1588